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Emergency Use Authorized for Ebola Virus Dx Test

Roche announced that the Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the LightMix Ebola Zaire rRT-PCR Test for use in patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as those traveling from West Africa.

The LightMix Ebola Zaire test is a one-tube duplex assay that detects Ebola Zaire virus and an endogenous human house-keeping gene used as an internal control. It is authorized for use with EDTA whole blood or TriPure-inactivated blood specimens. The process from whole blood sample preparation to results can be obtained for 96 results in a little over 3 hours. Through a manual extraction process, the LightMix Ebola Zaire test can also be used for a smaller number of samples.

A positive test result from the LightMix Ebola Zaire rRT-PCR Test indicates that the patient is presumptively infected with Ebola Zaire virus (detected in the West Africa outbreak in 2014). The test does not indicate the stage of infection, nor does it distinguish between different Ebola Zaire virus species. Laboratory test results should always be considered in the context of clinical observations and epidemiologic data in making a final diagnosis.

A negative test presumes that Ebola Zaire virus (detected in the West Africa outbreak in 2014) was not present at the detection level of the assay. However, negative results do not preclude Ebola virus infection, and should not be used as the sole basis for treatment, public health, or other patient management decisions. The clinical features of the illness and the type and risk of exposure are the keys to making patient management and isolation decisions. A negative LightMix Ebola Zaire rRT-PCR Test result should not be interpreted as demonstrating that the patient does not have Ebola virus infection. The possibility of a false negative result should especially be considered if the patient's recent exposures or clinical presentation indicate that Ebola virus infection is likely, and diagnostic tests for other causes of illness are negative.

The LightMix Ebola Zaire rRT-PCR Test is intended to run on the LightCycler 480 or cobas z 480 instruments.

The EUA will end when the U.S. Secretary of Health and Human Services' (HHS) declaration terminates, unless the FDA revokes it sooner.